Phase IV Drug Trials With a Canadian Site: A Comparison of Industry-Funded and Non-IndustryFunded Trials

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examining those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between ۲۰۰۰ and ۲۰۲۲, ۸۶۴ Phase IV trials were completed, with ۴۸۰ (۵۵.۶%) receiving industry funding and ۳۸۴ (۴۴.۴%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean ۲۰۴ enrollees versus ۷۰), more likely to be international (۵۷.۷% versus ۹.۶%) and reported results more promptly (۱.۲۱ years after completion versus ۱.۸۵ years), yet both types shared similar designs, outcomes, and completion times. Publication rates were ۸۱.۸% for industry-funded and ۶۵.۸% for non-industry-funded trials. The ClinicalTrials. gov registry displayed ۴۸ inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

Keywords:

Health Canada , Postmarket Trials , Phase IV Trials , Pharmaceutical Industry , Clinicaltrials.Gov , Completed Trials